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Why SafePASS®?

Since their introduction over 50 years ago, peel back pouches have become one of the most popular systems for delivering surgical devices onto the sterile field. However, it is widely recognized among peri-operative professionals that inadvertent contamination occurs during the opening and presentation of surgical devices with existing packaging systems. Many peri-operative professionals are aware of this situation and recognize the growing need for an improved packaging and sterile transfer system. This is especially true when the guidelines for sterile technique clearly mandate the course of action if there is any uncertainty regarding the occurrence of contamination during the sterile delivery.

To paraphrase one important recommendation:

“When in doubt, throw it out."

In reality this recommendation is becoming more difficult to practice as the interpretation of technical issues under “Managed Care” come into growing conflict with the Standards of Sterile Technique. This situation creates additional demands and substantially more stress on the peri-operative professional; especially in regards to maintaining appropriate quality standards and assuring improved patient outcome. As mandated by the Standards of Sterile Technique, two of the primary requirements for packaging surgical products are the protective containment of the contents and facilitating aseptic presentation onto the sterile field. Consequently, sterile surgical supplies and devices are packaged to comply with the following Association of Operating Room Nurses (AORN) recommendations:

“Package contents should be assembled, handled, and wrapped in a manner that provides for

an aseptic presentation of package contents.”

However, the correct method of opening and transferring supplies onto the sterile field is both controversial and can be a daunting challenge for the peri-operative nurse. At times, contamination during a sterile transfer is easily identified and can be properly addressed in compliance with the Standards of Sterile Technique.

However, all too frequently, contamination during the sterile transfer may be difficult to

observe; or is completely undetected.

Peri-operative professionals recognize both undetected and inadvertent contamination can frequently occur with existing packaging and delivery systems. While a solution has not been available, the financial loss from contamination during the sterile transfer has been considered a routine cost of doing business within the peri-operative environment. However, recent studies have revealed the clinical consequences and financial impact from surgical site infections (SSI’s) have been greatly underestimated. Within this context, the need for a more convenient and technically superior sterile packaging and delivery system seems obvious. SafePASS was developed to address this need and is available for use by surgical device manufacturers under licensing and royalty arrangement. We believe SafePASS can effectively reinforce brand differentiation and create a beneficial advantage in an increasingly competitive market. As an enhanced packaging/delivery system, surgical products packaged in SafePASS can be preferentially specified by end users based on the following benefits:Eliminates loss from inadvertent contamination

  • Single-layer convenience and double-layer protection
  • Relieves scrubbed personnel from assisting with sterile transfer
  • Complies with AORN recommendations
  • Supports 'Best Practices' programs
  • Enhances sterile technique containment
  • Assists quality control and improves patient outcome
  • Reduces risk of inadvertent contamination during transfer to the sterile field
  • Eliminates undetected contamination during the sterile transfer
  • Helps lower postoperative infection
  • Unprecedented cost savings

Sterile Containment Technology welcomes inquiries regarding the substantial competitive advantages SafePASS can deliver for visionary surgical device manufactures.


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